Atlas›Domain IX · Biomedical, neuro & digital›Guide 020
Guide IX-020

External trigeminal nerve stimulation for ADHD (Monarch eTNS)

2019USA
A 26 · L 68 · M 618 interventions in the Trinity explorer
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[source: …] where a claim comes from[uncertain] not confirmed in a primary source[synthesis] the writer's reconstruction

1. Introduction

Version followed: the US FDA authorisation of the Monarch external Trigeminal Nerve Stimulation (eTNS) System (De Novo DEN180041, announced 19 April 2019) and the indication carried over to the Generation 2.0 Monarch (510(k) K233293, January 2024), checked October 2026. Evidence status follows the FDA's 2019 summary, the McGough et al. 2019 pilot trial and the Conti et al. Nature Medicine phase 2b trial reported in January 2026.

The FDA classification, special controls and risks to health are as set out in the FDA's final classification order in the Federal Register (2021). The UK trial was checked against the Nature Medicine abstract, the ISRCTN registry record, King's College London's results release and the published trial protocol, and the AAP 2019 position against two US payer policies that quote the AAP guideline. The EU CE-mark history was checked against a 2015 trade-press report of NeuroSigma's announcement, and the pending US trial against its registry listing. The FDA De Novo decision summary, the full trial report, the AAP guideline's own text and the manufacturer's instructions for use are cited only through the sources named [uncertain].

Monarch eTNS is a prescription-only medical device. It is not a psychotherapy, and a psychotherapist does not prescribe or operate it. It is a cell-phone-sized unit connected by a wire to an adhesive patch placed on the forehead. It gives a low-level electrical stimulation to branches of the trigeminal nerve, which the FDA says should feel like tingling. Families use it at home while the child sleeps, under a caregiver's supervision [source: FDA press release 2019]. The idea behind it is that stimulating the trigeminal nerve affects brain regions involved in attention and arousal. The pilot authors linked active treatment to EEG changes in right frontal and frontal-midline regions, and those changes tracked improvement in hyperactive-impulsive symptoms. They treated this as a hypothesis, not an established mechanism [source: McGough et al. 2019]. In 2026 a larger UK sham-controlled trial found no benefit over sham. The device's effectiveness is therefore contested (see the evidence status in section 2) [source: KCL news 16 Jan 2026; Conti et al. 2026, Nature Medicine abstract].

This guide is for a psychotherapist working with a child and family alongside the prescribing clinician. Your role covers referral and medical review, psychoeducation, supporting the parents' consent and the child's assent, safeguarding, monitoring adverse effects and passing them on, and keeping evidence-based psychosocial ADHD treatment at the centre of care. The guide does not give stimulation settings, wear instructions beyond the general labelling description, or set-up steps. Those belong to the prescriber and the manufacturer's instructions for use [synthesis].

2. Framework

Regulatory status (as of October 2026, per the sources named)

  • United States, original authorisation: FDA De Novo marketing authorisation for NeuroSigma's Monarch eTNS System, announced 19 April 2019. The FDA called it the first non-drug ADHD treatment it had authorised. De Novo is the route for new low-to-moderate-risk device types, and it created a new classification that later devices can use through 510(k) [source: FDA press release 2019]. The FDA's final order records that NeuroSigma's De Novo request (DEN180041) was received on 30 July 2018 and the classification order issued on 19 April 2019, creating the device type "transcutaneous electrical nerve stimulator for ADHD". The classification was codified at 21 CFR 882.5898 with effect from 10 December 2021 [source: Federal Register final order, 10 Dec 2021; DEN180041 database record]. Classification: Class II (special controls), product code QGL [source: Federal Register 2021; DEN180041 database record; K233293 record; K232991].
  • Indication (labelling wording): treatment of paediatric ADHD as a monotherapy in patients aged 7 through 12 who are not currently taking prescription ADHD medication. It is intended for use in the home, under a caregiver's supervision, during periods of sleep [source: K233293; K232991]. The FDA states it should not be used in children under 7 [source: FDA press release 2019]. Note the age mismatch: the pivotal pilot enrolled children aged 8 to 12, while the labelled range starts at 7. The sources do not explain this [uncertain] [source: McGough et al. 2019].
  • Prescription: prescription use only [source: FDA press release 2019; K233293].
  • Later US devices with the same indication: Generation 2.0 Monarch eTNS (NeuroSigma), 510(k) K233293, decision 16 January 2024. It has a built-in rechargeable battery, a simplified interface and a lower maximum output. The indication is unchanged, and no new clinical data were submitted [source: K233293 record]. NeuroSigma announced the US commercial launch of Gen 2 on 21 July 2026 [source: NeuroSigma press release, BioSpace]. The Bistos BT-1000 eTNS System (South Korea) was cleared by 510(k) K232991 on 28 August 2024, with the Monarch as predicate and the same indication [source: K232991].
  • UK: NICE guidance does not recommend TNS for ADHD [source: KCL news 16 Jan 2026]. NICE NG87 covers psychosocial treatment and medication and does not cover eTNS [source: BCBSM policy summary of NICE; Molina policy MCP-392]. The authors of the UK trial report that NICE has said stronger evidence would be needed before such devices could be recommended on the NHS [source: KCL/The Conversation 23 Jan 2026]. No MHRA/UKCA status for an ADHD indication is documented in the cited sources [uncertain].
  • EU: NeuroSigma announced in November 2015 that the Monarch eTNS System had received a CE mark for ADHD in adults and in children aged 7 and over. It called this the first CE mark for a non-drug ADHD treatment in the EU [source: NeuroNews International 18 Nov 2015, reporting NeuroSigma]. A 2025 Danish trial protocol states that the device does not currently have an updated CE mark. It also states that eTNS is approved for drug-resistant epilepsy, not ADHD, in the EU, Canada and Australia [source: Edemann-Callesen et al. 2025]. The two sources conflict, and no current EU marking for ADHD was confirmed [uncertain].
  • US insurers: one large US insurer's policy (effective 1 July 2025) classes eTNS for ADHD as investigational and not covered. It notes that there are no Medicare coverage determinations [source: BCBSM/BCN policy].

Evidence status (as sources give it)

  • FDA basis (2019): a randomised trial of 62 children with moderate to severe ADHD. It compared eTNS with a placebo device, used nightly at home for four weeks. On the clinician-rated ADHD-RS, scores fell from an average of 34.1 to 23.4 with active treatment and from 33.7 to 27.5 with placebo. The FDA called the difference statistically significant [source: FDA press release 2019].
  • Pilot authors' own caveats: a small developmental sample; only acute (4-week) response; no study of use alongside standard treatments; about half of treated children had clinically meaningful improvement; benefits faded in a week off treatment. Unexplained weight and pulse increases were seen in the active group. Device-company affiliations and support are disclosed [source: McGough et al. 2019]. An earlier open trial with 24 children had no control group [source: Public Citizen 2023; BCBSM].
  • UK phase 2b trial (ATTENS, published 2026): a double-blind, randomised, parallel-group trial of 150 young people aged 8 to 18 with a clinical ADHD diagnosis, split evenly between real and sham stimulation, recruited through CAMHS clinics in five NHS trusts and run from London and Southampton; sponsored by King's College London and South London and Maudsley NHS Foundation Trust, funded by the NIHR/MRC Efficacy and Mechanism Evaluation programme and registered as ISRCTN82129325 [source: ISRCTN82129325 record; KCL news 16 Jan 2026; Rubia et al. 2024 protocol]. Parents applied the device at home nightly during sleep for four weeks; the sham device gave only minimal stimulation [source: ISRCTN record; KCL news 16 Jan 2026]. About 40% stayed on stimulant medication. The primary outcome was the investigator-administered, parent-rated ADHD Rating Scale [source: Rubia et al. 2024 protocol; ISRCTN record]. In the intention-to-treat analysis there was no significant difference between real and sham stimulation. There were no serious adverse events, and side-effect rates did not differ between groups [source: Conti et al. 2026, Nature Medicine 32(2):582–590, abstract]. Most secondary outcomes (objective activity, attention, mood, anxiety, sleep) also showed no difference; mind-wandering was the single exception. The result was the same in unmedicated participants. Blinding held, and most participants rated the device as little or no burden to use. The authors conclude that eTNS is safe but did not show clinical efficacy, that it should not be recommended as a primary ADHD treatment, and that US regulators should revisit the original evidence [source: KCL news 16 Jan 2026; PsyPost 19 Jan 2026; Conti et al. 2026 abstract]. A six-month follow-up was planned [source: Rubia et al. 2024 protocol; ISRCTN record]; six-month results are not reported in the cited sources [uncertain].
  • Contested: the manufacturer argues that the UK trial's parent-rated primary outcome may have limited what it could detect. It points to an ongoing UCLA double-blind trial of about 225 children with clinician-rated outcomes, with results expected in 2026 [source: KCL/The Conversation, reporting NeuroSigma]. That US trial is registered as NCT05374187 ("Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD"). It is sponsored by UCLA, runs at UCLA and Seattle Children's Hospital, enrols children aged 7 to 12 and compares active with sham stimulation. The registry listing shows it as completed, with a completion date of 10 April 2026 and a last update on 14 May 2026 [source: NCT05374187 listing via TundraSpace]. NeuroSigma's 2022 announcement described it as NIMH-funded, with up to 225 children and up to a year of open-label follow-up [source: NeuroSigma announcement Nov 2022, via Synapse]. The listing gives two different enrolment figures (218 and 180), and no results were found as of October 2026 [uncertain].
  • Professional bodies: the American Academy of Pediatrics' 2019 ADHD clinical practice guideline (Wolraich et al., Pediatrics 2019;144(4)) states that eTNS "cannot be recommended as a treatment of ADHD" without much more study of its efficacy and safety. It notes that the evidence is sparse compared with established treatments [source: AAP 2019 guideline as quoted in Regence policy 83.14 (2024) and Molina policy MCP-392 (2020)] [uncertain: guideline wording as quoted by payers]. No cited guideline recommends it [source: BCBSM; Molina; Edemann-Callesen et al. 2025].

Course of care around the device (phases for the psychotherapist)

The FDA and labelling give one structural point: the family should see their healthcare professional after four weeks, because response may take up to four weeks to show [source: FDA press release 2019]. The phases below organise the psychotherapist's work around that point. They are [synthesis], not a published protocol.

  1. Before any decision (1–2 sessions, parents with and without the child): clarify the diagnosis and who made it; map current psychosocial support; give balanced psychoeducation that includes the contested evidence; refer to or liaise with the prescriber. Move on when the family has a named prescriber, understands the evidence and the alternatives, and has decided with the prescriber whether to proceed.
  2. Consent and preparation (1 session): support the parents' informed consent and the child's age-appropriate assent; plan bedtime routines; set up a simple side-effect and observation log; agree how and when you will contact the prescriber. Move on when consent and assent are documented by the prescriber and a contact route has been agreed.
  3. Four-week trial period (weekly or fortnightly sessions): monitor side effects, sleep and family stress; keep parent training and environmental changes going; pass on concerns. Move on at the prescriber's four-week review.
  4. Review and next steps (1–2 sessions): help the family process the prescriber's review; support continuing, stopping or switching treatment as the prescriber advises; re-centre the care plan on the guideline-recommended treatments.
  5. Ongoing or after-device support: continue psychosocial ADHD treatment, school liaison and periodic review.

3. Guiding principles

  • The device belongs to the prescriber. Questions about whether to use it, how, for how long, or whether to stop go to the prescribing clinician. You never adjust or interpret settings [source: FDA press release 2019, prescription-only] [synthesis].
  • Stay within the labelled population. The labelling covers children aged 7–12 who are not on prescription ADHD medication, and it says not to use the device under age 7. If you notice a mismatch (a younger child, or a child also on medication), raise it with the prescriber; do not decide it yourself [source: FDA press release 2019; K233293].
  • Present the evidence honestly. FDA authorisation is not proof of effectiveness. Families should hear that a larger independent trial in 2026 found no benefit over sham [source: KCL news 2026; KCL/The Conversation 2026].
  • Psychosocial treatment is the core, not an extra. NICE recommends information and support, environmental modifications and ADHD-focused parent support for children aged 5 and over, and group parent training first-line for under-5s. Keep these going whatever the family decides about the device [source: NICE NG87 rationale].
  • Parents consent, the child assents, and both are heard. The device is applied to a sleeping child's face by a caregiver, so the child's understanding and agreement matter even though the parent consents [synthesis].
  • Safeguarding comes first. Supervised, labelled use at night is legitimate care. Coerced use, use outside labelling, home-made stimulators or any injury trigger your usual safeguarding procedures [synthesis].
  • Watch, record and pass on, without interpreting. Side effects are logged and reported to the prescriber promptly. Serious or unexpected events also go through official reporting routes [source: FDA press release 2019 adverse events] [synthesis].
  • Never advise a change. Keep ambivalence and adherence conversations open, but any decision to start, continue or stop goes back to the prescriber [synthesis].
  • Avoid shaming parents. NICE notes that an invitation to parent training does not imply poor parenting. Apply the same stance to families who want a non-drug option [source: NICE NG87 rationale].
  • Protect sleep. The device is used during sleep, and trouble sleeping and nightmares were among the reported effects, so bedtime and sleep are a focus of your monitoring [source: FDA press release 2019; McGough et al. 2019].

4. Intervention inventory

Part A describes how the treatment is delivered, at the descriptive level that official sources publish. Part B covers the psychotherapist's own interventions.

A1. Who prescribes and supplies it

  • Purpose: to know who the treating team is and where your role ends.
  • What sources say: the device is prescription-only. NeuroSigma tells families to consult a qualified healthcare provider about whether it is appropriate, and directs them to the product website for how to obtain it [source: FDA press release 2019; NeuroSigma press release 2026]. The cited sources do not name which professions may prescribe it [uncertain]. In US practice, prescribers are physicians or other licensed prescribers under state law [synthesis].
  • Watch for: direct-to-consumer marketing, waitlists or telehealth offers that skip a full ADHD assessment. Ask the family who made the diagnosis and who will review the child at four weeks [synthesis].

A2. How it is used, as the labelling describes it

  • Purpose: to give families an accurate, general picture, not operating instructions.
  • Description: a small unit connected by a wire to a single adhesive patch placed on the forehead. It is used at home during sleep, under caregiver supervision, and the stimulation should feel like tingling [source: FDA press release 2019]. Gen 2 adds a built-in rechargeable battery and a simplified screen [source: K233293; NeuroSigma press release 2026]. In the pivotal trial, parents were trained at the first visit to apply the patch and run the device, then gave the treatment each night [source: McGough et al. 2019]. The FDA's special controls require labelling to say the device is only for clean, intact skin [source: K233293 record].
  • Your stance: direct every operational question (settings, wear time, patch placement, intensity, troubleshooting) to the prescriber and the manufacturer's instructions for use. Do not coach the family on these [synthesis].

A3. Contraindications and warnings, as official sources state them

  • The FDA states it should not be used in children under 7.
  • It should not be used with an active implantable pacemaker or active implantable neurostimulator, or by children with body-worn devices such as insulin pumps.
  • It should not be used in an MRI scanner, because it has not been tested there.
  • It should not be used near mobile phones, because their electromagnetic energy may interrupt therapy [source: FDA press release 2019].
  • The FDA's special controls require the labelling to contraindicate use with implanted metallic or electronic devices in the head, cardiac pacemakers, and implanted or wearable defibrillators, and to warn that the device is for clean, intact skin only. The FDA identified these risks to health for the device type: adverse tissue reaction; injury or discomfort from electrical stimulation, including burns and nerve damage; misuse leading to device failure, discomfort or injury; and skin irritation or infection from use on broken skin [source: Federal Register final order 2021; K233293 record; BCBSM].
  • Long-term effects and long-term safety have not been established [source: BCBSM, citing the FDA summary; Molina policy MCP-392].
  • Your use: when a family mentions a medical device, an upcoming MRI or surgery, or a new medication, prompt them to tell the prescriber [synthesis].

A4. The four-week review

  • What sources say: patients should consult their healthcare professional after four weeks to assess the effect, because response may take up to four weeks to show [source: FDA press release 2019]. In the pilot, ratings were taken weekly, and scores worsened in both groups during a week off treatment [source: McGough et al. 2019].
  • Your use: put the review date in your own plan. Prepare the family to bring observations from home and school [synthesis].

A5. Adverse effects, as labelling and trials describe them

  • FDA list of the most common effects: drowsiness, increased appetite, trouble sleeping, teeth clenching, headache and fatigue. The FDA states that no serious adverse events were associated with the device [source: FDA press release 2019; repeated in NeuroSigma press release 2026].
  • Pilot trial detail: headache, fatigue, drowsiness, nightmares, increased appetite and teeth clenching were more frequent with active treatment. Skin whitening or discolouration at the patch site occurred in both arms and resolved. Weight and pulse rose more in the active group, with unclear significance. No one withdrew because of side effects [source: McGough et al. 2019]. Public Citizen also lists frequent urination and skin rash, and calls the safety picture questionable [source: Public Citizen 2023].
  • UK trial: no serious adverse events. Mild events (headache, fatigue, skin irritation) were similar in both arms [source: KCL news 2026; PsyPost 2026].

B1. Recognising when to suggest medical review or referral

  • Purpose: to make sure a family considering or using the device has a proper ADHD assessment and a responsible prescriber.
  • Steps: (1) Ask who diagnosed ADHD, when, and with what assessment. (2) Screen in general terms for things that need a doctor's view: sleep disorders, epilepsy or seizures, cardiac history, implanted or body-worn devices, skin conditions on the forehead, current medication. (3) If there is no prescriber, or the child is outside the labelled age range or on prescription ADHD medication, suggest the family discuss it with the prescriber or GP/paediatrician before going further. (4) With consent, write a short referral or liaison note that states your observations, not a recommendation for or against the device [synthesis; labelled population and contraindications from source: FDA press release 2019].
  • Example language (illustrative): "Before you decide, it would help to have your paediatrician look at this with you. They can check whether it's suitable for Sam and what else is on the table."
  • Watch for: a family buying or borrowing a device without a prescription, or using one meant for another child. Treat this as a safety concern (see B10).

B2. Psychoeducation for parents

  • Purpose: to give accurate, balanced information so parents can talk with the prescriber on an equal footing.
  • Steps: (1) Ask what they have heard and what they hope for. (2) Explain in plain terms what the device is and how the labelling says it is used (A2), who it is authorised for, and that it is prescription-only. (3) Describe the evidence: one small FDA trial showed a group difference; a larger independent UK trial in 2026 found no benefit over sham; the manufacturer disputes this and a US trial is pending. (4) Name the evidence-based alternatives NICE describes: information and support, environmental modifications, ADHD-focused parent support or training, medication when needed, and CBT for older young people. (5) Give the common side effects. (6) Check understanding by asking them to explain it back [sources: FDA press release 2019; KCL news 2026; NICE NG87 rationale] [synthesis for the sequence].
  • Example language (illustrative): "The FDA allowed it to be sold based on one small study. A bigger study in the UK this year didn't find it worked better than a dummy device. So it's a genuine open question, and your doctor can help you weigh it."
  • Watch for: parents taking FDA clearance to mean proven effectiveness, or feeling guilty about medication. Working well means parents can state both sides of the evidence and name at least one other treatment.

B3. Psychoeducation for the child

  • Purpose: to give the child a developmentally pitched understanding that supports assent and lowers anxiety about a device used during sleep.
  • Steps: (1) Use simple, concrete words, a drawing or the real patch shown by the prescriber; you do not demonstrate the device. (2) Explain that it is a sticker on the forehead and a small box, that it may tingle, and that a grown-up looks after it at night. (3) Invite questions and worries (fear of electricity, of being hurt, of being 'fixed'). (4) Stress that ADHD is not their fault and that other help (routines, school support, family work) continues [synthesis; description from source: FDA press release 2019].
  • Example language (illustrative): "Your doctor might suggest trying a sticker that goes on your forehead while you sleep. Some kids feel a tingle. You can always tell Mum or Dad, or me, if it feels funny or you don't like it."
  • Watch for: fear, embarrassment (for example about sleepovers), or the child seeing the device as proof something is 'wrong with their brain'.

B4. Supporting informed consent, assent and shared decision-making

  • Purpose: to help parents give informed consent to the prescriber and the child give meaningful assent. You are a support to the process; you do not take consent for the device.
  • Steps: (1) Help parents list their questions for the prescriber: expected benefit, the 2026 evidence, side effects, what happens at four weeks, cost and insurance cover, alternatives, and what follows if it does not help. (2) Explore values: preference for non-drug treatment, fears about medication, school pressures. (3) Seek the child's views separately and together, in age-appropriate terms. Record whether the child agrees, objects or is unsure, and pass this on to the prescriber with consent. (4) Where parents disagree with each other, or parental responsibility is shared or contested, flag this to the prescriber; follow your service's consent policy and local law [synthesis]. (5) Note that the trial behind the authorisation used parents' expectations as part of the evidence, and that the UK authors found strong placebo responses. Name this neutrally so expectations are realistic [source: McGough et al. 2019; KCL news 2026].
  • Example language (illustrative): "Let's write down what you want to ask Dr Lee. What would make this worth trying for you, and what would make you stop?"
  • Watch for: decisions driven by pressure from school, cost, or one parent overriding the other; a child who clearly objects. A child's objection is a reason for the prescriber and family to reconsider [synthesis].

B5. Child safeguarding

  • Purpose: to keep a child who receives a night-time device under caregiver control safe.
  • Steps: (1) Hold the usual safeguarding frame: a supervised, prescribed device used as labelled is ordinary care. (2) Escalate under your local procedures if you learn of: use in a child under 7 or outside prescription; a home-made or modified stimulator; skin injury that is not explained by mild patch-site effects; restraint or punishment around applying the device; the device being used as a threat or a condition; or a child who repeatedly objects being overridden. (3) Where there is immediate risk, follow your safeguarding procedure without waiting for the review. (4) Record what the child and parent said in their own words [synthesis; age and supervision from source: FDA press release 2019; clean intact skin from K233293 record].
  • Example language (illustrative): "I need to make sure everyone is safe, so I'm going to talk with Dr Lee about what you've told me. I'll tell you what I'm doing."
  • Watch for: siblings using the device; adults borrowing it; online advice to adapt general-purpose TENS units.

B6. Integrating psychosocial ADHD treatment

  • Purpose: to make sure the child gets the treatments guidelines recommend, whatever happens with the device. The device's label is monotherapy (no prescription ADHD medication). It does not exclude psychosocial care, but its use alongside standard treatments was not studied [source: K233293; McGough et al. 2019].
  • Steps: (1) Start or continue ADHD-focused parent support or training. NICE recommends offering all parents and carers of children aged 5 and over ADHD-focused group support, which may be as few as one or two sessions, and group parent training first-line for under-5s. (2) Agree environmental modifications at home and school (routines, seating, task breakdown, reduced distraction), apply them systematically, and review their effect. (3) For older young people where CBT is indicated, keep that available [source: NICE NG87 rationale]. (4) Keep the timing of a new psychosocial component separate from the device's start date where you can, so that changes can be read more clearly. Tell the prescriber what else changed during the trial period [synthesis].
  • Example language (illustrative): "Whatever you decide about the device, the routines plan and the parent group are still the backbone. Let's keep those going."
  • Watch for: parents dropping parent training because 'the device will fix it', or hearing a parent-training referral as blame. NICE says to tell parents explicitly that it does not imply poor parenting [source: NICE NG87 rationale].

B7. Bedtime and sleep support

  • Purpose: the device is used during sleep, and trouble sleeping, drowsiness, fatigue and nightmares were reported [source: FDA press release 2019; McGough et al. 2019]. Sleep-related problems also commonly come with ADHD [synthesis].
  • Steps: (1) Take a brief sleep history before the device starts (bedtime, settling, waking, nightmares, daytime sleepiness). (2) Help the family keep a calm, predictable bedtime routine that the device's application fits into, without changing anything the prescriber has set. (3) Monitor sleep weekly during the trial period, and pass on any changes to the prescriber. (4) If the child resists bedtime because of the patch, explore fears and offer coping strategies (choice in parts of the routine, a reassuring object, praise) [synthesis].
  • Example language (illustrative): "Let's keep bedtime the same as before, just with the sticker step added. What part of the routine could Sam choose?"
  • Watch for: new or worse sleep problems, nightmares, or daytime drowsiness at school. Record these and pass them on (B8).

B8. Monitoring and passing on adverse effects

  • Purpose: to make sure side effects and concerns reach the prescriber quickly and accurately.
  • Steps: (1) Offer a simple weekly home log (parent and child versions): sleep, appetite, mood, headaches, tiredness, teeth clenching, skin at the patch site, and anything else new. Base it on the effects official sources list (A5) without reproducing any rating scale. (2) Review the log at each session. (3) With consent, send the prescriber a brief factual summary before the four-week review, and sooner for anything new or worrying. (4) Tell parents to contact the prescriber, or urgent care, directly for skin injury, a seizure, fainting, or anything that alarms them; you do not triage medical symptoms. (5) Serious or unexpected device problems can be reported through the regulator's official route: in the US the FDA's device adverse-event reporting (MedWatch), in the UK the MHRA Yellow Card scheme. The prescriber normally leads this [synthesis; reporting routes named from general knowledge, uncertain].
  • Example language (illustrative): "You've noticed more headaches this week. That's exactly what Dr Lee needs to hear. Shall I send a note today, or would you rather call?"
  • Watch for: parents downplaying side effects because they badly want a non-drug option, or a child hiding discomfort to please the parent.

B9. Adherence and ambivalence conversations

  • Purpose: to help families stay in honest contact with the prescriber, without you advising them to start, continue or stop.
  • Steps: (1) Ask neutrally how the nights have gone, including missed nights and why. (2) Reflect both sides of any ambivalence (hope versus burden, side effects, doubts after the 2026 news). (3) Problem-solve practical barriers that do not involve the device's operation, such as bedtime conflict, sibling disruption or shared rooms. (4) Bring any wish to stop, change or extend use back to the prescriber [synthesis].
  • Example language (illustrative): "It sounds like part of you wants to give it the full four weeks and part of you is fed up. Both make sense. That's worth taking to Dr Lee rather than deciding on your own."
  • Watch for: guilt or conflict between parents; a child pressured into nightly use; families feeling they 'failed' the device.

B10. Do-it-yourself and off-label use: risk conversation

  • Purpose: to prevent families using improvised or unauthorised stimulation on a child.
  • What sources say: the authorised device carries contraindications, warnings and a clean-intact-skin requirement, and long-term effects are unknown. The FDA's listed risks for this device type include burns, nerve damage, skin irritation or infection, and injury from misuse [source: FDA press release 2019; Federal Register final order 2021; K233293 record; BCBSM]. The cited sources do not document specific harms from home-made trigeminal stimulation [uncertain].
  • Steps: (1) Ask, non-judgementally, whether the family has seen online advice to use general TENS units, consumer 'brain stimulators' or adapted devices. (2) Explain that these have not been authorised for children with ADHD, that their safety for a child's face and head during sleep is unknown, and that the authorised device itself is prescription-only, with known contraindications and side effects. (3) If a child is being stimulated with an improvised device, treat this as a safety concern and escalate (B5) [synthesis].
  • Example language (illustrative): "I understand wanting to try something now. A device from the internet hasn't been checked for children's heads at night, so please don't use one. Let's take your questions to Dr Lee."
  • Watch for: a family that keeps returning to online stimulation advice, or any sign of an improvised device or unexplained skin marks on the child's face. Working if device questions go to the prescriber rather than being tried out at home [synthesis].

B11. Supporting the four-week review, ending and after

  • Purpose: to help the family use the prescriber's review well and keep momentum in psychosocial care.
  • Steps: (1) In the week before, help the family put together observations from home, school and the log. (2) After the review, help them understand the prescriber's advice and their feelings about it: relief, disappointment, or a wish to try medication or more psychological work. (3) If the device is stopped, normalise this; the pilot saw symptoms rise again in both groups after treatment stopped, so families should watch for that and keep supports in place [source: McGough et al. 2019; four-week review from FDA press release 2019]. (4) Revise the care plan around NICE-recommended options. If medication is now being considered, refer that conversation to the prescriber [source: NICE NG87 rationale] [synthesis].
  • Example language (illustrative): "Dr Lee and you decided to stop. That's useful information, not a failure. Let's look at what's helped most this month and build on it."
  • Watch for: hopelessness ('nothing works'), or blaming the child.

B12. Liaison with the treating team and school

  • Purpose: to give one coherent picture of the child across settings.
  • Steps: (1) With parental consent (and the child's assent where appropriate), agree what information you share with the prescriber and school, and how. (2) Ask teachers for observations without telling them which treatment the child is having, if the family prefers. In the UK trial, school response rates were too low to use teacher ratings, so plan teacher input early [source: PsyPost 2026] [synthesis]. (3) Share your observations, not conclusions about device effectiveness [synthesis].
  • Example language (illustrative): "Would you be happy for me to ask Sam's teacher for a quick note on mornings and concentration over the next month?"
  • Watch for: school staff drawing conclusions about the device, or the child feeling singled out or monitored. Working if observations flow both ways and the child is comfortable with the arrangement [synthesis].

B13. Crisis and safety planning

  • Purpose: ADHD in children often comes with emotional dysregulation, family stress and other conditions. A device trial can add pressure [synthesis].
  • Steps: (1) Keep your usual risk assessment, including self-harm and family-conflict screening, appropriate to age. (2) Agree with parents who to call for device problems (prescriber or manufacturer support), for medical emergencies (emergency services), and for mental-health crises (local crisis services). (3) Write a short family safety plan if there are risk concerns [synthesis].
  • Example language (illustrative): "If a night at home gets really hard, who would you call first? Let's write the numbers down together so everyone knows which one is for what."
  • Watch for: self-harm talk from the child, escalating family conflict or carer exhaustion. Working if the family knows which contact is for device problems, medical emergencies and mental-health crises [synthesis].

5. Handling problems

The cited sources do not address psychotherapy problems around this device. All the responses below are [synthesis] unless a source is given.

  • Parents treat FDA authorisation as proof it works. Separate 'allowed to be sold' from 'shown to work'. Summarise the 2019 and 2026 trials neutrally, and suggest they ask the prescriber how the newer evidence affects the recommendation [source for evidence: FDA press release 2019; KCL news 2026].
  • Parents want the device to avoid medication at any cost. Explore fears about medication with empathy. Do not argue for or against medication. Make sure guideline-recommended psychosocial treatment is in place and that the medication question goes to the prescriber [source: NICE NG87 rationale].
  • The child is under 7, or already on prescription ADHD medication. This is outside the labelled population [source: FDA press release 2019; K233293]. Raise it with the family and prescriber; do not support use outside labelling yourself.
  • The child refuses, or bedtime becomes a battle. Stop pushing the routine. Explore the child's reasons, and bring the objection to the parents and prescriber as part of the assent picture. Do not coach parents in techniques for forcing night-time application. Return to standard behavioural bedtime strategies for the rest of the routine.
  • Side effects the family is minimising. Normalise reporting. Use the log, and send the prescriber a factual summary with consent (B8). Weight and pulse rose in the pilot's active group, so prompt routine medical review rather than interpreting it yourself [source: McGough et al. 2019].
  • The family stops using it without telling the prescriber. Respect their decision. Encourage them to tell the prescriber, and keep psychosocial care going.
  • Disappointment or 'nothing works' after four weeks. Validate it. Review what has helped (routines, school changes, parent strategies), and re-plan around NICE-recommended options [source: NICE NG87 rationale].
  • Parents in conflict about the device. Hold a joint session focused on shared goals for the child. Flag any dispute over parental responsibility to the prescriber, and follow consent law and policy.
  • Rupture with the therapist (for example, parents feel you are 'against' the device after you shared the 2026 trial). Acknowledge the impact, restate that the decision belongs to them and the prescriber, and explain that your job is to make sure they have the full picture.
  • Cost, insurance refusal or waitlists. Some US insurers class it as investigational [source: BCBSM/BCN policy]. Help the family put their energy into accessible psychosocial treatment while they decide.
  • Improvised devices or online hacks. Respond as in B10. Escalate under safeguarding procedures if a child is at risk.
  • Anxiety about electricity or 'brain changes' in the child. Give simple, accurate information (B3), offer coping strategies, and let the prescriber know if the anxiety persists.
  • New evidence appears (for example, results from the US UCLA/Seattle trial NCT05374187, listed as completed in April 2026). Re-check sources, update your psychoeducation, and tell families that the picture has changed [source for the trial: KCL/The Conversation 2026, reporting NeuroSigma; NCT05374187 listing via TundraSpace]. Status checked October 2026.
  • Your own role creep. If you notice yourself answering questions about settings, wear time or troubleshooting, stop and redirect to the prescriber and the manufacturer's instructions.

Sources

Sources:

Cited indirectly [uncertain]:

  • FDA De Novo decision summary for DEN180041: the classification, special controls and risks to health are taken from the FDA's final classification order in the Federal Register (listed above); the trial results come from the FDA press release.
  • Wolraich ML et al. (2019). Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents (American Academy of Pediatrics). Pediatrics 144(4). Its eTNS statement is cited as quoted in the Regence and Molina policies.
  • The manufacturer's instructions for use and product website are not used as sources here.
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